- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07050927
- Original Trial
Long-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in Infants
Long-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in Infants: A Randomized Controlled Longitudinal Study
This study type is a clinical trial (randomized controlled longitudinal study). The primary purpose is to determine whether an online occupational therapy-based parent training program can prevent or reduce feeding problems, improve parental attitudes, and decrease parenting stress in mothers of infants.
The participant population includes female caregivers (mothers) of typically developing infants aged 18 to 24 months. All participants are healthy volunteers.
The main research questions this study aims to answer are:
Does online occupational therapy-based parent training reduce feeding problems in infants (e.g., food refusal, resistance, sensory-based rejection)? Does the training improve maternal attitudes related to feeding and reduce parenting-related stress? Comparison group: Researchers will compare the outcomes of mothers who receive the online training (intervention group) with those who receive no intervention (control group) to determine the effectiveness of the program.
Participants will be asked to:
Complete baseline assessment forms prior to randomization
If in the intervention group:
Attend a 4-week online group training program (one session per week) via a secure Zoom® platform Participate in follow-up assessments at 6 months and 12 months post-training
All participants (in both groups) will:
Complete standardized assessment tools at three time points (baseline, 6-month follow-up, 12-month follow-up), including:
Sociodemographic Information Form Infant Adaptive Feeding Behavior Scale Feeding Process Parental Attitude Scale Parenting Stress Scale
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey (Türkiye), 0650
- Ankara Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mothers of typically developing infants aged between 18 and 24 months
- Mothers who report a stress level of 7 or above on a visual analog scale regarding their child's feeding process
- Mothers who have the necessary technical equipment to follow the occupational therapy training via online platforms
Exclusion Criteria:
- Infants born prematurely or diagnosed with significant neurological or developmental conditions
- Infants who receive any diagnosis during the intervention or follow-up period
- Mothers in the intervention group who miss more than one training session
- Mothers who are currently receiving or have previously received occupational therapy or feeding counseling
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parent Training Group
Participants in this group will receive a 4-week online occupational therapy-based parent training via secure Zoom sessions.
The training focuses on feeding skills development, sensory strategies, parenting attitudes, and stress management.
Participants will complete assessments at baseline, 6 months, and 12 months using standardized tools to evaluate infant feeding behavior, parental attitudes, and parenting stress
|
The intervention is a 4-week online parent training program based on occupational therapy principles, delivered via secure Zoom sessions once per week.
Each session lasts approximately 60-75 minutes and focuses on topics such as feeding skill development, sensory-based feeding difficulties, responsive parenting strategies, and stress management techniques.
The training includes interactive discussions and practical suggestions for daily feeding routines.
Supporting materials, such as PDF slides and short demonstration videos, are shared with participants after each session.
Attendance in at least three sessions is required to remain in the study.
|
|
No Intervention: Non-intervention Group
Participants in this group will not receive any intervention during the study period.
They will complete the same assessments as the intervention group at baseline, 6 months, and 12 months to monitor changes in infant feeding behavior, parental attitudes, and parenting stress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptive Eating Behavior in Infancy Scale
Time Frame: T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up
|
The Infant Adaptive Feeding Behavior Scale (IAFBS) was developed by Dilsiz and Dağ in 2018 to assess the eating behaviors of children aged 9 to 36 months. The scale consists of 20 items and four factors: "Reluctance," "Resistance," "Reaction to Main Meal Structure," and "Sensory-Related Food Refusal." Items 1-8 measure the reluctance factor; items 9-12 measure resistance; items 13-16 assess reactions to meal structure; and items 17-20 evaluate food refusal related to sensory issues. Items are rated on a 5-point Likert scale ranging from "Never" to "Always," scored as follows: never = 1, rarely = 2, sometimes = 3, usually = 4, always = 5. However, item 2 ("reaches spontaneously for food during meals") reflects a positive feeding behavior and is reverse-scored. All other items are scored in the standard direction. The total score ranges from 20 to 100. Higher total and subscale scores indicate more severe feeding behavior problems in infants aged 9 to 36 months. |
T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up
|
|
Maternal Attitudes Scale in the Feeding Process
Time Frame: T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up
|
This scale was developed in 2018 by Dilsiz and Dağ with the aim of identifying problematic areas in maternal attitudes during the feeding process, based on the interactional dimension of feeding between the mother and child.
The Feeding Process Parental Attitude Scale (FPPAS) is used to assess the feeding-related attitudes of mothers with children aged 9 to 72 months.
It is a 5-point Likert-type scale with response options ranging from "Never" to "Always."
The scale consists of 27 items and includes the following subscales: Negative Emotional State During Meals, Attitudes Toward Inadequate/Unbalanced Nutrition, Negative Feeding Strategies, Forceful Feeding, and Reaction to Others' Opinions.
The total score ranges from 27 to 135.
Higher scores on the total scale and subscales indicate a greater presence of problematic maternal attitudes regarding the feeding process.
|
T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up
|
|
Parental Stress Scale
Time Frame: T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up
|
The Parenting Stress Scale was developed by Aydoğan and Özbay in 2017 to measure the stress experienced by parents of typically developing children in relation to their parenting role.
The scale consists of 18 items and has a single-factor structure that includes the parent, the parent-child relationship, and characteristics of the child.
It is a Likert-type instrument rated from 0 ("Does not describe at all") to 4 ("Describes very well").
The total score ranges from 0 to 72, with higher scores indicating higher levels of parenting stress.
The scale is easily applicable to parents who have at least one child and have completed primary education or higher.
|
T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Decision No: 112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Food Neophobia
-
Instituto Politécnico de LeiriaUniversidade do PortoCompletedPreschool Children
-
University of LouisvilleOatly Group ABRecruitingDietary Habits | Food Preferences | Food NeophobiaUnited States
-
University of Colorado, DenverPurdue University; The Sugar AssociationCompletedParenting | Food NeophobiaUnited States
-
The University of Texas Medical Branch, GalvestonTerminatedAnxiety State | Avoidant Restrictive Food Intake Disorder | Picky Eating | Food NeophobiaUnited States
-
Yale UniversityHispanic Health Council, Inc.; Wholesome WaveCompletedFood Insecurity | Food Preferences | Food SelectionUnited States
-
University of MinnesotaCompletedFood Insecurity | Healthy Diet | Nutritional Quality | Food Legislation | Food Stamp ProgramUnited States
-
University of the Basque Country (UPV/EHU)Bioaraba Health Research Institute; Basque Government Department of Public... and other collaboratorsActive, not recruiting
-
University at BuffaloNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruiting
-
NYU Langone HealthNational Cancer Institute (NCI); New York University; National Institutes of...RecruitingFood Selection | Calorie Consumption | Food ChoicesUnited States
-
University of LiverpoolUniversity of Bristol; Liverpool John Moores UniversityCompletedFood Labelling | Food Choice | PMEUnited Kingdom
Clinical Trials on Online occupational therapy group training
-
Ankara Medipol UniversityCompletedFeeding and Eating Disorders | Child Behavior Problem | Feeding Behavior | Occupational Therapy | Online InterventionTurkey
-
NYU Langone HealthIcahn School of Medicine at Mount SinaiCompletedStroke | HemiparesisUnited States
-
Çankırı Karatekin UniversityCompletedPregnancy Related | Postpartum ComplicationTurkey (Türkiye)
-
University of MalagaCompletedWell-being | Individuality | Self-EfficacySpain
-
Universidad de ZaragozaAsociación Española de EsclerodermiaActive, not recruitingScleroderma | Systemic Sclerosis (SSc) | Scleroderma (Limited and Diffuse)Spain
-
Children's Hospital of Eastern OntarioThe Hospital for Sick Children; University of Ottawa; Université de MontréalUnknownPain | Juvenile Idiopathic ArthritisCanada
-
Cairo UniversityCompletedSports Physical TherapyEgypt
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompleted
-
Hacettepe UniversityUnknownAutism Spectrum Disorder | Feeding Disorder | Sensory Integration Disorder (Disorder)
-
Dokuz Eylul UniversityThe Scientific and Technological Research Council of TurkeyRecruiting